Status:
ACTIVE_NOT_RECRUITING
An Evaluation of Patient Reported Outcomes and Clinical Outcomes
Lead Sponsor:
Renibus Therapeutics, Inc.
Conditions:
Post-Operative Complications in Cardiac Surgery
Eligibility:
All Genders
18+ years
Brief Summary
This extension study is being conducted to assess the following objectives through 12 months post-cardiac surgery: * Patient reported outcomes (PRO), using the EQ-5D questionnaire * Clinical outcomes
Eligibility Criteria
Inclusion
- Subjects must have completed the REN-007 study to be eligible to participate in the Extension Study.
Exclusion
- Subjects who did not complete the REN-007 study are not eligible to participate in the Extension Study.
- Female subjects who become pregnant during the REN-007 study are not eligible to participate in the Extension Study.
Key Trial Info
Start Date :
October 16 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
379 Patients enrolled
Trial Details
Trial ID
NCT06092970
Start Date
October 16 2023
End Date
June 30 2026
Last Update
August 1 2025
Active Locations (39)
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1
Research Site
Huntsville, Alabama, United States, 35801
2
Research Site
San Francisco, California, United States, 94107
3
Research Site
Stanford, California, United States, 94305
4
Research Site
Washington D.C., District of Columbia, United States, 20010